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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device guide, wire, catheter, neurovasculature
Product CodeMOF
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTIRIA MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICRO VENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
RAPID-MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 18 18
2021 39 39
2022 92 92
2023 91 91
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 99 99
Fracture 90 90
Break 26 26
Detachment of Device or Device Component 19 19
Adverse Event Without Identified Device or Use Problem 16 16
Insufficient Information 8 8
Material Fragmentation 8 8
Material Split, Cut or Torn 4 4
Inaccurate Information 3 3
Material Separation 3 3
Stretched 2 2
Solder Joint Fracture 2 2
Material Integrity Problem 1 1
Contamination 1 1
Migration or Expulsion of Device 1 1
Appropriate Term/Code Not Available 1 1
Device Damaged Prior to Use 1 1
Malposition of Device 1 1
Unsealed Device Packaging 1 1
Unclear Information 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 206 206
Foreign Body In Patient 19 19
No Consequences Or Impact To Patient 17 17
Perforation of Vessels 11 11
Intracranial Hemorrhage 6 6
Hemorrhage/Bleeding 4 4
Insufficient Information 4 4
Hypersensitivity/Allergic reaction 3 3
Muscle Weakness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 2 2
No Patient Involvement 2 2
Vascular Dissection 1 1
No Code Available 1 1
Foreign Body Embolism 1 1
Nausea 1 1
Paralysis 1 1
Paresis 1 1
Increased Sensitivity 1 1
Vasoconstriction 1 1
Autoimmune Reaction 1 1
Stroke/CVA 1 1
Embolism 1 1
Headache 1 1
Inflammation 1 1
Numbness 1 1
Obstruction/Occlusion 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Weakness 1 1
Tingling 1 1
Dysphasia 1 1

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